title: Regulations and guidelines should be strengthened urgently for re-evaluation on post-marketing medicines in China.
abstract: This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on postmarketing surveillance (also named pharmacovigilance), therefore, their regulation systems are nearly perfect. In China, the regulations on post-marketing re-evaluation and relative technical guidelines do not cover the whole aspects, even lack in some important aspects, and long-term risk management mechanisms have not been established. So it is urgent to establish new regulations and improve the regulatory system in China based on the existing regulations and guidelines, by learning from the ideas of foreign advanced regulations, then fully integrating them with China's actual conditions, and cooperating with multidisciplinary researchers.
authors.affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
authors.forename: Yan-Ming
authors.initials: YM
authors.lastname: Xie
authors.forename: Feng
authors.initials: F
authors.lastname: Tian
mesh_terms: D002681:China; D019049:Developed Countries; D004335:Drug and Narcotic Control; D017408:Guidelines as Topic; D011358:Product Surveillance, Postmarketing